installation and operation guide LATITUDE Link data management system 6215 LATITUDE Link Viewer 6216 LATITUDE Link Import Utility

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1 installation and operation guide LATITUDE Link data management system 6215 LATITUDE Link Viewer 6216 LATITUDE Link Import Utility

3 TABLE OF CONTENTS LATITUDE LINK DATA MANAGEMENT SYSTEM OVERVIEW Intended Use... 1 Contraindications... 1 How the LATITUDE Link Data Management System Works... 1 INSTALL AND SET UP THE LATITUDE LINK DATA MANAGEMENT SYSTEM Installation Overview... 2 Install and Set Up the Main Station... 3 Install and Set Up Additional Data Import Stations (Optional)... 5 USING THE LATITUDE LINK DATA MANAGEMENT SYSTEM Import and Transfer Data to the EMR System... 6 Import from removable media... 6 Import using Bluetooth file transfer... 6 View Follow-up List... 6 Manage Clinic... 7 Manage Configuration... 7 Manage Data Upload to BSC... 7 Manage Clinic Users... 7 Delete Follow-up Data... 7 MAINTENANCE Software Updates... 8 Backing Up and Restoring Data... 8 APPENDIX A: OTHER INFORMATION Protecting LATITUDE Link Data... 9 Enabling Secure Communication... 9 System Requirements...10 APPENDIX B: SYMBOLS Symbol Definitions...11 LATITUDE Link is a trademark of Boston Scientific Corporation The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. microsd is a trademark or registered trademark of SD-3C, LLC. Firefox is a registered trademark of the Mozilla Foundation. Chrome is a trademark of Google Inc. Internet Explorer is a registered trademark of Microsoft Corporation 2016 Boston Scientific Corporation or its affiliates. All rights reserved. Published Printed in the United States of America

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5 LATITUDE LINK DATA MANAGEMENT SYSTEM OVERVIEW The purpose of this document is to provide health care providers and information technology personnel with a basic understanding of the LATITUDE Link Data Management System. These persons may use this document to: Become familiar with components of the system Determine how to install and configure the system Understand how to use and maintain the system Having a basic understanding of the system components, processes, and associated terminology can help support the system and troubleshoot any problems that might arise. Intended Use The LATITUDE Link Data Management System is intended to transfer select patient and device data from Boston Scientific programming systems to Electronic Medical Record (EMR) systems or to Boston Scientific systems. The LATITUDE Link Data Management System also makes select patient and device data available for viewing and allows for viewing and printing of associated PDF reports. Contraindications The LATITUDE Link Data Management System is contraindicated for use with any implanted device data other than data from compatible Boston Scientific implanted devices. Not all Boston Scientific implanted device data sets are compatible with the LATITUDE Link Data Management System. How the LATITUDE Link Data Management System Works Health care providers conduct follow-ups or other device checks on patients with Boston Scientific implanted devices using Boston Scientific programming systems. The health care provider uses removable media (e.g. a USB flash drive or a microsd card) or other means (e.g. Bluetooth wireless technology) to import patient data from a programming system into the LATITUDE Link Data Management System. The LATITUDE Link Data Management System transfers the data to the EMR system and (for S-ICD devices) uploads the data to Boston Scientific. Health care providers can use the LATITUDE Link Data Management System to view the transfer and upload status of data records, and re-send records. For S-ICD devices, they can view device data associated with a record and view and print reports. For non-s-icd devices, they can view and print reports. System Overview 1

6 INSTALL AND SET UP THE LATITUDE LINK DATA MANAGEMENT SYSTEM Installation Overview The LATITUDE Link Data Management System uses a single designated computer (the main station) to transfer device data received from Boston Scientific programming systems to the clinic EMR system in a compatible format. Other computers on the clinic network may be used as data import stations. These computers can collect programming system data and forward it to the main station. Data Import Station Data Import Station Main Station Data Import Station Data Import Station The LATITUDE Link Data Management System consists of two software applications: 1. The LATITUDE Link Import Utility (installed on both the main and data import stations) The Import Utility imports programming system device data using any of the following means: Removable media (e.g., a USB flash drive or a microsd card) Bluetooth wireless technology 2. The LATITUDE Link Viewer (installed on the main station) The Viewer receives programming system device data from one or more Import Utility installations and transfers the data to an EMR system in a configured data format. The Viewer makes S-ICD device data and reports available for viewing and printing and may also upload S-ICD data to Boston Scientific servers to help facilitate Boston Scientific technical support services. For non-s-icd devices, the Viewer makes reports available for viewing and printing. Other computers connected to the network can be used to access the LATITUDE Link Viewer using a web browser. Important: In order to avoid sending duplicate records to the EMR system, install the LATITUDE Link Viewer software on the designated main station only. Do not install it on the data import stations. Note: To ensure correct installation, software updates, and application function the following conditions must be met: Both the main station and data import stations must maintain a connection to the Internet. The main station must maintain a network connection to the desired EMR system. Each data import station must maintain a network connection to the main station. 2 Installation overview Installation overview 2

7 Install and Set Up the Main Station Note: Installation of the LATITUDE Link Viewer requires administrator-level access on the main station. If you do not have that level of access, ask your system administrator to perform the installation. 1. Use the Information Required For Latitude Link Viewer Setup form to gather information about your clinic s EMR system. 2. Go to the LATITUDE Link download site ( from the designated main station. Download and run the LATITUDE Link Viewer installation file. Follow the on-screen prompts and instructions to perform the installation. When the installation process is complete the Viewer itself will start and a configuration screen will appear. 3. The LATITUDE Link Viewer URL listed on the configuration screen is used when installing the LATITUDE Link Import Utility on other computers. Record the URL if you plan to do this. URL: 4. Enter the configuration information from the setup information form completed in step 1 above. Important: Incorrect EMR Connectivity settings could lead to the transfer of follow-up data including personal data to an unintended destination. 5. Once the required configuration information has been entered, review and modify the remaining options as desired. 6. Go to the LATITUDE Link download site ( Download and run the LATITUDE Link Import Utility installation file. Note: Installing the LATITUDE Link Import Utility does not require administrative privileges. 7. The Import Utility window will be displayed after installation. Close this window. You can access the Import Utility at any time by using its icon in the system tray, which is located near the computer s date and time display. 8. Setup of the main station is now complete. Note: The Import Utility is installed specifically for each user account on the computer. If other users log into this computer and intend to use the Import Utility, each user must install the software from their account. Repeat steps 6 and 7 for each additional user. 9. If you want to set up additional computers that can send implanted device data from a programming system to your EMR system, please go to each of these computers and follow the instructions in the Install and Set Up Additional Data Import Stations (Optional) section of this document. Install and Setup Main Station 3

8 INFORMATION REQUIRED FOR LATITUDE LINK VIEWER SETUP The following configuration parameters are used to complete the setup of the main station. Check with your system administrator to determine each value. Clinic name to use in the EMR system Clinic or facility name EMR Integration format Generic HL ORU version 1 XML version 5.0 (Paceart) HL ORU version 1 (Centricity) IDCO (IHE PCD-09 revision 2.0) EMR Transfer Method & Connection Information File Drop MLLP HTTP (used with Paceart XML format) File Drop Location: MLLP Host Name: HTTP Host Name: Port: Port: EMR Message Language Language used in EMR system messages 4 Information Required for Setup Information Required for Setup 4

9 Install and Set Up Additional Data Import Stations (Optional) Important: Optional data import stations should have only the LATITUDE Link Import Utility software installed. Do not install the LATITUDE Link Viewer software that was installed on the main station on a data import station. 1. Go to the LATITUDE Link download site ( Download and run the LATITUDE Link Import Utility installation file. Note: Installing the LATITUDE Link Import Utility does not require administrative privileges. 2. After the application is installed, it will start automatically and open to the configuration window. 3. De-select the option that indicates the LATITUDE Link Viewer is installed on this computer. 4. Replace the contents of the LATITUDE Link Viewer URL field with the network location that you recorded during step 3 of the Install and Set Up the Main Station section. Note: The LATITUDE Link Viewer URL is found on the manage configuration option of the Viewer s manage clinic menu. 5. Save the configuration and close the Import Utility window. You can access the Import Utility at any time by using its icon in the system tray, which is located near the computer s date and time display. 6. Setup of the data import station is now complete. Note: The Import Utility is installed specifically for each user account on the computer. If other users log into this computer and intend to use the Import Utility, each user must install the software from their account. Repeat steps 1-5 for each additional user. Install and Setup Optional Stations 5

10 USING THE LATITUDE LINK DATA MANAGEMENT SYSTEM Import and Transfer Data to the EMR System Follow-up data can be imported into the LATITUDE Link Data Management System using removable media or Bluetooth wireless technology. Note: Follow-up data imported into the LATITUDE Link Data Management System can include personal data of the type that is generally kept protected. Please refer to APPENDIX A: OTHER INFORMATION on page 9 for further information. Import from removable media To import follow-up data from removable media, insert the media into a computer that has the LATITUDE Link Import Utility installed. The Import Utility will retrieve the data and send it to the LATITUDE Link Viewer, where it can be transferred (either automatically or manually) to the EMR system or uploaded to Boston Scientific. Import using Bluetooth file transfer In order to successfully transfer follow-up data using Bluetooth wireless technology, the data-exporting equipment (e.g. programming system) must first be paired with the LATITUDE Link Import Utility computer. Follow the pairing instructions provided with the sending equipment to accomplish this. Next, the LATITUDE Link Import Utility application must be configured to import data from its own computer s Bluetooth exchange folder. Check the Bluetooth settings of the computer to determine the folder path that is in use. Access the LATITUDE Link Import Utility configuration by clicking on its application icon found in the system tray which is located near the computer s date and time display and selecting the change configuration option. Enter the computer s Bluetooth exchange folder path into the folder configuration field. Follow-up data is sent to the LATITUDE Link Data Management System by initiating the file transfer process on the external system (e.g. programming system) once the Bluetooth connection has been established. The Import Utility will retrieve the data and send it to the LATITUDE Link Viewer, where it can be transferred (either automatically or manually) to the EMR system or uploaded to Boston Scientific. View Follow-up List The LATITUDE Link Viewer provides the ability to view the list of follow-ups that have been imported into the LATITUDE Link Data Management System, as well as the status of their transfer to the EMR system. Follow-ups can also be sent or re-sent to the EMR system by selecting the desired records and initiating the transfer to EMR. Detailed S-ICD follow-up data may be viewed by selecting the individual record. The Viewer also allows you to view and print all reports imported into LATITUDE Link from the Programmer via removeable media or Bluetooth wireless technology. From the View Follow-up List screen, click the Reports button. A PDF opens containing all reports included in the data that was imported. By default, the Viewer is automatically launched after a data import operation is complete. It may also be accessed independently by using the shortcut located in the Boston Scientific folder within the start menu (Start > All Programs > Boston Scientific folder). 6 Using the System Using the System 6

11 Manage Clinic Manage Configuration The LATITUDE Link Data Management System offers several post-installation configuration options. These include the following: choice of which reports to include in EMR messages (available reports from this group are combined into one file for EMR transfer); whether or not follow-up data is automatically transferred to the EMR system; whether or not follow-up S-ICD data is automatically uploaded to Boston Scientific; EMR connectivity settings; and secure communication management (See Enabling Secure Communication on page 9). Manage Data Upload to BSC Imported S-ICD data may be uploaded to Boston Scientific (BSC) and can be used if assistance is needed from Boston Scientific Technical Services. A list of follow-ups and their BSC upload status may be viewed and follow-ups may be sent or re-sent to BSC by selecting the desired records and initiating the upload to BSC. Note: The default configuration is that S-ICD follow-up data is automatically uploaded to Boston Scientific. This data may be aggregated with data from other LATITUDE Link Data Management Systems. The automatic upload feature can be disabled via the Manage Configuration user interface. Manage Clinic Users LATITUDE Link user access control is not enabled by default during installation. A designated administrator may enable this feature following installation in order to create and manage user accounts. Delete Follow-up Data The LATITUDE Link Data Management System stores all imported follow-up data indefinitely. This makes it possible for users to re-send follow-ups to the EMR system and/or BSC, or to view details for select implanted devices. Follow-up data records can be deleted from the LATITUDE Link Data Management System at any time, if desired. Using the System 7

12 Important: Follow-ups that have been deleted from the LATITUDE Link Data Management System will not be available for re-sending or viewing, and they cannot be re-imported into the LATITUDE Link Data Management System. MAINTENANCE Software Updates Software updates for either the LATITUDE Link Viewer or the LATITUDE Link Import Utility may become available. User notification will be provided when updates are released. To update the LATITUDE Link Viewer, run the LATITUDE Link Updater program installed with the application and follow the provided instructions. To update the LATITUDE Link Import Utility, simply select the software update option when it is presented. Important: The installed software must be kept up-to-date in order to ensure that important changes have been applied. Continued use of software that is out-of-date can increase exposure to possible issues with data accuracy or functionality that are addressed in the updated software. Backing Up and Restoring Data Follow-up data stored by the LATITUDE Link Data Management System may be backed up by copying the entire contents of the installed database location to a suitable location. The data may be restored by completely overwriting the installed database location with the backup contents. 8 Maintenance Maintenance 8

13 Protecting LATITUDE Link Data APPENDIX A: OTHER INFORMATION Follow-up data imported into LATITUDE Link Data Management System includes personal data which is stored unencrypted in the LATITUDE Link Data Management System database. In order to keep this personal data protected, the file system location containing the system database must have appropriate access controls in place. Data encryption and file security are not part of the LATITUDE Link Data Management System. The LATITUDE Link Data Management System employs the computer s basic delete function when commanded by the user to remove follow-up data from its database. Therefore, deleted follow-up data which contains personal data should be protected by making deleted file data unrecoverable at the computer file system level. Enabling Secure Communication Important: This setup requires a computer administrator with expertise in SSL communication. Secure communication with the LATITUDE Link Viewer is not enabled by default during installation. Enabling secure communication allows for encrypted communication between the Import Utility and the Viewer and between a web browser and the Viewer. In order to enable this capability, an encryption key pair and certificate must be provided to the application. The following steps should be performed by someone with SSL expertise and with administrative-level access to the main station where the Viewer is installed: 1. Retrieve Key Pairs and Certificates Coordinate with an existing public key infrastructure (either internal to your organization or through a third party) to generate the following items: A key pair consisting of a public key and a private key. A certificate signed by a trusted Certificate Authority. Important: The certificate must list the common name that matches the LATITUDE Link Viewer fully qualified network name. This can be found on the Viewer configuration page as the LATITUDE Link Viewer URL. For example, if the configuration page shows the URL computer123.myclinic.com/latc, then the network name to use would be computer123. myclinic.com. Provide the key pair and certificate in a PKCS#12 formatted file that is protected with the password provided by the public key infrastructure. Important: If the signing Certificate Authority is an intermediary, the PKCS#12 store must have the certificate chaining included. APPENDIX A: Other Information 9

14 2. Configure the LATITUDE Link Viewer From the computer with the Viewer software installed, navigate to the installation folder and the config subfolder. Edit the file latitude-link.properties with the following changes: Update latitude.link.keystore.path to add the keystore path and file name (e.g. latitude. link.keystore.path=<path and filename>). If the file name is specified with no path, the current path is used (i.e., the config subfolder). Update latitude.link.keystore.password to add the keystore password provided by the public key infrastructure (e.g., latitude.link.keystore.password=<password>). Update latitude.link.ssl.port to specify the desired SSL port number (e.g. latitude.link.ssl. port=<port number>. Important: This configuration file will contain critical information about accessing the security key information. In order to keep this information protected, ensure that proper file system access controls are in place for this file. 3. Restart the LATITUDE Link Viewer service via the Windows Services program. SSL communication will be enabled once these steps have been completed. This can be confirmed by navigating to the main Viewer page and ensuring that the browser has secure communication enabled (i.e. the https protocol is in use and the security padlock icon indicates a secure connection). System Requirements The LATITUDE Link Viewer and Import Utility were developed to run on the Windows operating system. The LATITUDE Link Viewer was developed to support the following web browsers: Internet Explorer Mozilla Firefox Google Chrome Note: The LATITUDE Link Viewer and Import Utility were developed with operating systems and browsers that were current at that time. The software may not function properly when using operating system or browser versions that were subsequently released. Contact Boston Scientific Technical Services at CARDIAC ( ) or your local affiliate for a list of supported operating systems and web browsers. 10 APPENDIX A: Other Information APPENDIX A: Other Information 10

15 APPENDIX B: SYMBOLS Symbol Definitions The following symbols may be used on packaging and labeling. Symbol Meaning Reference Number Manufacturer Authorized Representative in the European Community Australian Sponsor Address APPENDIX B: Symbols 11

Australian sponsor address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 Cardiac Pacemakers

16 Manufacturer Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN USA Authorized representative in the European Community Guidant Europe NV/SA; Boston Scientific Green Square, Lambroekstraat 5D 1831 Diegem, Belgium Australian sponsor address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone Free Fax Cardiac Pacemakers Incorporated 4100 Hamline Avenue North St. Paul, MN USA Manufactured at: Cardiac Pacemakers Incorporated 4100 Hamline Avenue North St. Paul, MN USA CARDIAC ( ) * * en Worldwide

Patient Data Management

OPERATOR S MANUAL Patient Data Management Application for use with the LATITUDE Programming System Model 3931 Patient Data Management Model 3300 LATITUDE Programming System CAUTION: Federal law (USA) restricts